Lidocaine Supplement for Minimal Invasive Parathyroid Surgery

Parathyroid Disease Clinical Trial

Official title:

Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00528502
• Other study ID #: 2006-0147
• Status: Withdrawn
• Phase: Phase 3
• First received: September 11, 2007
• Last updated: December 5, 2012
• Start date: June 2006
• Est. completion date: January 2008

Study information

• Verified date: December 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

1. To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.

Description:

Lidocaine is a local anesthetic that causes numbness to the throat when misted into the air. This numbness in the throat should stop the urge to clear the throat in the middle of the operation. Therefore, this should stop the interruptions during the surgery.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Participants in Group 1 will receive the saline mist. This will moisturize and soothe the throat. Participants in Group 2 will receive the lidocaine mist. Lidocaine or saline is misted into the air that you breathe during the surgery. You and your surgeon will not be told which group you were assigned to. At the end of the surgery, your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial.

You will be considered off-study once you are sent to the recovery room after surgery.

This is an investigational study. Lidocaine is FDA-approved and commercially available for local anesthesia. If you are in the lidocaine or the saline group. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE Lee.

Exclusion Criteria:

• Patients who are excluded will be any who require elective endotracheal intubation as a preoperative decision by the anesthesia team. These patients will be those with sleep apnea, BMI>35, uncontrolled gastro esophageal reflux.

• Patients who have a history of allergy/hypersensitivity to lidocaine.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parathyroid Disease
• Parathyroid Diseases

Intervention

Drug:
• Lidocaine
Lidocaine is misted into the air that you breathe during the surgery.
• Saline
Saline is misted into the air that you breathe during the surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Airway Interruption		Assessment made by surgeon during minimally invasive parathyroidectomy surgery	No
Primary	Quality of Operative Field		Assessment made by surgeon during minimally invasive parathyroidectomy surgery	No

External Links

•   UT MD Anderson Cancer Center official web site